Safety and efficacy of dedicated guidewire, microcatheter, and guide catheter extension technologies for chronic total coronary occlusion revascularization: Primary results of the Teleflex Chronic Total Occlusion Study

Catheter Cardiovasc Interv. 2022 Feb;99(2):263-270. doi: 10.1002/ccd.29962. Epub 2021 Sep 28.

Abstract

Background: Description of procedural outcomes using contemporary techniques that apply specialized coronary guidewires, microcatheters, and guide catheter extensions designed for chronic total occlusion (CTO) percutaneous revascularization is limited.

Methods: A prospective, multicenter, single-arm study was conducted to evaluate procedural and in-hospital outcomes among 150 patients undergoing attempted CTO revascularization utilizing specialized guidewires, microcatheters and guide extensions. The primary endpoint was defined as successful guidewire recanalization and absence of in-hospital cardiac death, myocardial infarction (MI), or repeat target lesion revascularization (major adverse cardiac events, MACE).

Results: The prevalence of diabetes was 32.7%; prior MI, 48.0%; and previous bypass surgery, 32.7%. Average (mean ± standard deviation) CTO length was 46.9 ± 20.5 mm, and mean J-CTO score was 1.9 ± 0.9. Combined radial and femoral arterial access was performed in 50.0% of cases. Device utilization included: support microcatheter, 100%; guide catheter extension, 64.0%; and mean number of study guidewires/procedure was 4.8 ± 2.6. Overall, procedural success was achieved in 75.3% of patients. The rate of successful guidewire recanalization was 94.7%, and in-hospital MACE was 19.3%. Achievement of TIMI grade 2 or 3 flow was observed in 93.3% of patients. Crossing strategies included antegrade (54.0%), retrograde (1.3%) and combined antegrade/retrograde techniques (44.7%). Clinically significant perforation resulting in hemodynamic instability and/or requiring intervention occurred in 16 (10.7%) patients.

Conclusions: In a multicenter, prospective registration study, favorable procedural success was achieved despite high lesion complexity using antegrade and retrograde guidewire maneuvers and with acceptable safety, yet with comparably higher risk than conventional non-CTO PCI.

Trial registration: ClinicalTrials.gov NCT03988166.

Keywords: chronic total occlusion; guide catheter extensions; guidewires; microcatheters; percutaneous coronary intervention.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Catheters
  • Chronic Disease
  • Coronary Angiography / methods
  • Coronary Occlusion* / diagnostic imaging
  • Coronary Occlusion* / etiology
  • Coronary Occlusion* / therapy
  • Humans
  • Percutaneous Coronary Intervention*
  • Prospective Studies
  • Registries
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT03988166